Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 45

Probiotics to reduce weight gain from antipsychotic medications

Official title: : EFFECT OF PROBIOTIC SUPPLEMENTATION ON ATYPICAL ANTIPSYCHOTIC INDUCED WEIGHT GAIN IN PATIENTS ATTENDING PSYCHIATRIC CLINICS AT AINSHAMS UNIVERSITY HOSPITALS (A RANDOMIZED CONTROLLED TRIAL)

Run by Ain Shams University · NCT06936137 · Data updated 2026-11-12

This study is testing if taking probiotics can help adults with schizophrenia avoid weight gain from their antipsychotic medications.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 45 Years
SexAll
Enrollment180 (estimated)
SponsorAin Shams University
Academic / other
Locations1 site (Cairo, Abbassia)
StatusRecruiting
StartedApril 20, 2025
Main results expectedJune 20, 2026
Study endsDecember 20, 2026
Registry record updatedApril 20, 2025
Trial IDNCT06936137 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18-45 with schizophrenia who have gained more than 10% of their body weight after starting atypical antipsychotics.

Probably not a fit

Patients with gastrointestinal diseases or those currently taking probiotics, fiber supplements, antibiotics, or laxatives may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of probiotic supplementation in reducing weight gain associated with atypical antipsychotic medications in adult patients diagnosed with schizophrenia. The study will involve a randomized controlled design, where participants will receive lactobacillus LS to assess its impact on weight and psychological well-being. The primary objective is to evaluate the reduction in weight gain, while the secondary objective focuses on the psychological state of the patients. The trial aims to enhance treatment compliance and overall quality of life for patients on antipsychotic medications.

Why it matters

Potential benefit: If successful, this study could help patients manage weight gain caused by antipsychotic medications, improving their overall health and treatment adherence.

How similar studies have gone: While the specific approach of using probiotics for this purpose may be novel, there is existing research indicating potential benefits of probiotics in managing weight and psychological health.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult schizophrenia patients (18-45 years) on second generation antipsychotics Stable patients with a total positive and negative syndrome scale (PANSS) score of ≤60.

With more than 10% weight gain after taking atypical antipsychotics for at least 3 months with treatment duration not more than two years.

Exclusion Criteria:

1. Taking probiotics, fiber supplements, antibiotics and laxatives in the last 6 weeks.
2. Comorbid gastrointestinal diseases, including active peptic ulcer, uncontrolled and recurrent diarrhea, gastrointestinal bleeding, and digestive system neoplastic diseases.

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Where it's running

  • AinShams university hospitals
    Cairo, Abbassia, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.